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Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Primary Purpose

Dry Eye Syndromes

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast 5% Ophthalmic Solution
Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
Sponsored by
Eye Surgeons of Indiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  • 18 years of age or older
  • Signs and symptoms of DED
  • Consent to treat with topical immunomodulator
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Altered nasolacrimal flow of either acquired, induced, or congenital origin
  • Hypersensitivity to dexamethasone
  • Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
  • Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Sites / Locations

  • Eye Surgeons of Indiana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Xiidra Only Group

Xiidra + Dextenza Group

Arm Description

Patients with dry eye disease Xiidra only

Patients with dry eye disease Xiidra + Dextenza

Outcomes

Primary Outcome Measures

Mean change in ocular surface staining
As measured by sodium fluorescein and lissamine green
Patient Preference for therapy
As measured by COMTOL Survey

Secondary Outcome Measures

Mean change in MMP-9
As measure by InflammaDry
Mean change in tear break-up time (TBUT)
As measured by TBUT testing
Mean change in conjunctival injection
As measured on a scale of 0-4 and graded by the physician
Change from baseline in meibomian gland scores (expressibility and quality)
As measured on a grading scale 1 to 4 and graded by the physician
Mean change in tear osmolarity
As measured by Tear Lab
Mean change in DEQ-5
As measured by the DEQ-5 Questionnaire
Mean change in Best-corrected Visual Acuity (BCVA)
As measure by ETDRS

Full Information

First Posted
May 28, 2020
Last Updated
April 11, 2022
Sponsor
Eye Surgeons of Indiana
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04413253
Brief Title
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
Official Title
Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye Surgeons of Indiana
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
Detailed Description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xiidra Only Group
Arm Type
Active Comparator
Arm Description
Patients with dry eye disease Xiidra only
Arm Title
Xiidra + Dextenza Group
Arm Type
Experimental
Arm Description
Patients with dry eye disease Xiidra + Dextenza
Intervention Type
Drug
Intervention Name(s)
Lifitegrast 5% Ophthalmic Solution
Other Intervention Name(s)
Xiidra
Intervention Description
To reduce signs and symptoms of dry eye disease
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
Other Intervention Name(s)
Dextenza, Xiidra
Intervention Description
To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
Primary Outcome Measure Information:
Title
Mean change in ocular surface staining
Description
As measured by sodium fluorescein and lissamine green
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Patient Preference for therapy
Description
As measured by COMTOL Survey
Time Frame
Assessed at Week 12 Visit
Secondary Outcome Measure Information:
Title
Mean change in MMP-9
Description
As measure by InflammaDry
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Mean change in tear break-up time (TBUT)
Description
As measured by TBUT testing
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Mean change in conjunctival injection
Description
As measured on a scale of 0-4 and graded by the physician
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Change from baseline in meibomian gland scores (expressibility and quality)
Description
As measured on a grading scale 1 to 4 and graded by the physician
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Mean change in tear osmolarity
Description
As measured by Tear Lab
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Mean change in DEQ-5
Description
As measured by the DEQ-5 Questionnaire
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Title
Mean change in Best-corrected Visual Acuity (BCVA)
Description
As measure by ETDRS
Time Frame
Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: 18 years of age or older Signs and symptoms of DED Consent to treat with topical immunomodulator Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: Patients under the age of 18. Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) Active infectious systemic disease Active infectious ocular or extraocular disease Altered nasolacrimal flow of either acquired, induced, or congenital origin Hypersensitivity to dexamethasone Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS) Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damon Dierker, OD, FAAO
Organizational Affiliation
Eye Surgeons of Indiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46040
Country
United States

12. IPD Sharing Statement

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Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

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